IRB review is required when an activity constitutes human subjects research. Quality Improvement (QI) and Quality Assurance (QA) projects always involve human subjects, but only have to be submitted to the IRB for review if they meet the definition of research. The IRB, in partnership with Boston Medical Center quality and patient safety leadership, has official guidelines to distinguish when QI/QA projects do and do not require IRB review. The HRPP has also established an exempt category for QI/QA projects without external funding that do require IRB review because they also meet the definition of research.
To help determine whether or not your project requires IRB review, please use the following checklist:
This checklist is also embedded into the electronic QI Hub application through the BU Barry M. Manuel Office of Continuing Medical Education for tracking patient safety QI/QA projects throughout Boston Medical Center and Boston University. The mission of QI Hub is to create and support a culture of healthcare quality improvement (QI) engagement for BMC, the Boston HealthNet Community Health Centers and Boston University through accredited education, mentorship and administrative oversight.
More information about quality improvement and quality assurance activities may be found by:
- Contacting us; and
- In our CR TIMES Feature Article Quality Improvement/Quality Assurance Projects – When Do They Require IRB Review?(June 2021 Edition); and
- In our HRPP Policies and Procedures